According to MedPage Today, the advisory panel voted 13-7 yesterday to approve the drug, despite some questions on both its efficacy and its safety. First of all, Contrave doesn't help patients lose that much weight. Over 30% of study subjects lost 5% of their body weight on it, which is one of the FDA's standards for weight-loss drugs. But after a year, Contrave patients lost just 4.2% more than control patients, failing to meet another FDA standard — a 5% difference between drug group and control. And for control patients who were also enrolled in a "lifestyle modification program," the difference was even tinier, meaning that Contrave may not be that much more effective than the old standby: diet and exercise.
Also, while eating healthier foods and working out tends can lower your blood pressure, Contrave can actually raise it. Those who lost more weight on Contrave did appear to have lower blood pressure than those who lost less, but the lowest of all was found in the diet and exercise group. All of which is a little concerning if the whole point of losing weight is really about improving health.
Oh yeah, and Contrave could also make you have a seizure. But the panel is apparently willing to let this stuff ride — they agreed that they want more data on cardiovascular risk, but they're willing to wait for it until after the drug is approved. Because a great time to see if something is safe is after you say it is. MedPage points out that the FDA doesn't have to abide by the panel's recommendation, but they often do. Contrave is slated to go up for a full vote by January 31. The stock price of its manufacturer, Orexigen, more than doubled at the news. So at least someone's benefiting from this drug.
FDA Panel Endorses Contrave Weight-Loss Drug [MedPage Today, via ABC]
Orexigen Gains From Rivals' Failures To Win Panel Backing For Diet Pill [Bloomberg]
New Diet Pill Clears FDA Panel [Newser]
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